Intervention combining nurse navigators (NNs) and a mobile application versus standard of care (SOC) in cancer patients (pts) treated with oral anticancer agents (OAA): Results of CapRI, a single-center, randomized phase III trial.

• DOI: 10.1200/jco.2020.38.15_suppl.2000
• Publication Date: 2020-05-25T15:17:49Z
• Authors: Olivier Mir; Marie Ferrua; Aude Fourcade; Delphine Mathivon; Adeline Duflot-Bo...; Sarah Naomie Dumont; Eric Baudin; Suzette Delaloge; David Malka; Laurence Albiges; Patricia Pautier; Caroline Robert; David Planchard; Stéphane de Botton; François Lemare; Marilene Guillet; Vanessa Puglisi; May Abbas; Mario Di Palma; Etienne Minvielle
• Keywords: Clinical endpoint

2000 Background: Various interventions aiming to improve a safe use of oral anti-cancer agents have previously been reported. These retrospective studies involved nurse-led follow-up and health technologies. However, the potential impact these combined strategies is limited by lack rigorous methodology. Methods: We performed randomized phase 3 trial comparing an intervention combining NNs mobile application vs. SOC in cancer pts treated with OAA (excluding hormonal therapy) our tertiary center. Pts initiating (all types cancer, PS < 3, life expectancy > 6 months), were 1:1 basis. The nursing-led for patients. provided regular phone follow-ups manage symptoms assess toxicities, adherence supportive care needs. had access record tracking data, contact via secure messaging or dedicated line. lasted months. primary endpoint was Relative Dose Intensity (RDI). Secondary endpoints included adherence, toxicity, response survival, quality life, experience (PACIC Score), end-of-life support, economic estimation healthcare resources. Results: From October 2016 May 2019, 609 (median age: 62 years, 20-92; PS2: 11.8%) included. 39% receiving chemotherapy, 61% other OAA. RDI significantly higher CAPRI arm (93.4% ±0.26 89.4% ±0.19, p = 0.04). also improved PACIC scores (mean: 2.94±0.83 2.67±0.89, 0.01), number unplanned hospitalizations (15.1% 22.0%, 0.04), hospitalization duration 2.82±6.96 days 4.44±9.60, 0.02), treatment-related grade≥3 toxicities (27.6% 36.9%, 0.02). Conclusions: Compared SOC, RDI, experience, their duration, as well rate toxicities. This type should represent new standard Clinical information: NCT02828462.